search
Back to results

Effects of Two Hypocaloric Diets on Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
LC-P-LGI diet
LC-CONV
Sponsored by
Ceprodi S.A. Kot
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring obesity, dietary treatment, high protein diet, Low glycaemic index, adipocytes, fat mass, systemic inflammatory markers, improvement of complications, effect on weight loss

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 26 to 35 Kg/m2
  • 25 to 60 years old
  • non diabetic subjects

Exclusion Criteria:

  • SGOT and SGPT >2.5x the normal
  • plasma glucose more than 1.26 g/l
  • hepatic or renal or cardiac failure

Sites / Locations

  • Assistant pubique-hopitaux Paris

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 9, 2011
Last Updated
March 10, 2011
Sponsor
Ceprodi S.A. Kot
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Pierre and Marie Curie University, Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT01312740
Brief Title
Effects of Two Hypocaloric Diets on Weight Loss
Official Title
Effects of Two Hypocaloric Diets on Weight Loss and Inflammatory Markers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ceprodi S.A. Kot
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Pierre and Marie Curie University, Assistance Publique - Hôpitaux de Paris

4. Oversight

5. Study Description

Brief Summary
The investigators evaluated whether an energy-restricted protein diet with low glycaemic index carbohydrates and soluble fibers (LC-P-LGI) would be more effective than a conventional diet (LC-CONV) on weight-loss and related metabolic variables.
Detailed Description
The subjects (9 men and 5 post-menopausal women) were randomly allocated, in a cross-over design, to two periods of 4 weeks of an energy restricted diet of 1200 kcal as either a conventional diet (LC- CONV) or a special energy restricted diet compensated by proteins (LC-P-LGI). The two nutritional periods were separated by a wash-out interval of 8 weeks. Before the start of the study, all subjects were instructed to maintain their usual lifestyle during the experimental period.Anthropometric parameters, glucose and lipid homeostasis and inflammatory markers were evaluated before and after each dietary period.Body fat and fat-free mass distributions were measured by a dual-energy X-ray absorptiometry (DXA, GE Lunar Prodigy Corporation, Madison, WI, USA) before and after each dietary period at the fasting state.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, dietary treatment, high protein diet, Low glycaemic index, adipocytes, fat mass, systemic inflammatory markers, improvement of complications, effect on weight loss

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
LC-P-LGI diet
Intervention Description
a hypocaloric diet low in lipids (25%) which is compensated by proteins (35%) with no change in carbohydrate content.
Intervention Type
Other
Intervention Name(s)
LC-CONV
Intervention Description
4-week CONV period consisted in the subjects' consumption of 1200 Kcal/ day (25% protein, 31% lipids, 44% carbohydrates).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 26 to 35 Kg/m2 25 to 60 years old non diabetic subjects Exclusion Criteria: SGOT and SGPT >2.5x the normal plasma glucose more than 1.26 g/l hepatic or renal or cardiac failure
Facility Information:
Facility Name
Assistant pubique-hopitaux Paris
City
Paris
ZIP/Postal Code
75004
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22170375
Citation
Rizkalla SW, Prifti E, Cotillard A, Pelloux V, Rouault C, Allouche R, Laromiguiere M, Kong L, Darakhshan F, Massiera F, Clement K. Differential effects of macronutrient content in 2 energy-restricted diets on cardiovascular risk factors and adipose tissue cell size in moderately obese individuals: a randomized controlled trial. Am J Clin Nutr. 2012 Jan;95(1):49-63. doi: 10.3945/ajcn.111.017277. Epub 2011 Dec 14.
Results Reference
derived

Learn more about this trial

Effects of Two Hypocaloric Diets on Weight Loss

We'll reach out to this number within 24 hrs